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Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna's mission is to establish a leading-edge research, development, and manufacturing facility at Harwell, as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS and government partners across the UK. We're looking for global experts eager to join us in this endeavour, contributing to a future where access to life-saving vaccines is a reality for all. As a Qualified Person (QP), reporting to the Site Quality Head, you will play a critical role in ensuring the release of Moderna’s innovative mRNA-based drug products aligns with the strictest regulatory standards. This pivotal position sits at the core of our UK manufacturing operations, ensuring all certified batches comply with The Human Medicines Regulations 2012 and EU GMP, including Annex 16. You will bring advanced knowledge of biologics and sterile products and meet the eligibility criteria to be named on the Manufacturer’s Authorisation from the MHRA. You’ll be the key authority for certifying batches for release and be integral to Quality leadership at the Harwell site — directly influencing both compliance and continuous improvement across the Pharmaceutical Quality System.
Job Responsibility:
Acting as the named Qualified Person (QP) on Moderna’s site licence(s)
Certifying and authorising batch releases in full compliance with The Human Medicines Regulations 2012, EU GMP (Annex 16, and where applicable, Annex 13), and MHRA guidance
Ensuring sterile drug product batches meet cGMP, approved specifications, and the conditions of the Marketing or Clinical Trial Authorisation
Maintaining oversight of the PQS as it pertains to QP responsibilities, ensuring it is fit for purpose
Escalating GMP or product quality concerns related to safety and efficacy to senior leadership
Participating as a member of the site and country Quality teams, promoting strong quality culture and QRM principles
Attending and reporting at the Quality Management Review Forum
Overseeing delegated activities and ensuring proper training of personnel or third parties
Leading or participating in self-inspections, external audits, and Quality Risk Assessments
Serving as the QP point of contact for Technical/Quality Agreement reviews and approvals
Reviewing and approving deviations, OOS, OOT, excursions, CAPAs, risk assessments, and other batch-impacting quality records
Reviewing and approving electronic batch records (eBR) and associated documentation for batch release
Monitoring emerging regulatory guidance and ensuring continued compliance through internal assessments
Providing Quality oversight for validation and qualification of GMP facilities, utilities, and equipment
Overseeing product technology transfers from a Quality perspective
Collaborating cross-functionally to drive Quality culture and embed a continuous improvement mindset.
Requirements:
A Life Science degree and/or relevant postgraduate qualification, with a minimum of 10 years’ experience in quality roles within the biotechnology and/or pharmaceutical industry
Eligibility to act as a Qualified Person (QP), with demonstrable knowledge of biologics and sterile manufacturing sufficient to be named on the site’s licences issued by the MHRA
Commitment to maintaining QP status through ongoing Continuing Professional Development
Experience working in GMP-regulated pharmaceutical / biological manufacturing environments
Expert knowledge of Pharmaceutical Quality Management Systems, including their application across the product lifecycle
Extensive understanding of GxP requirements for both early-phase clinical trial materials and commercial products, including interpretation and application of EU GMP and associated MHRA guidance
Demonstrated, in-depth understanding of broader GMP principles, industry standards, and current trends shaping the regulatory landscape
Experience as a qualified pharmaceutical auditor (internal and/or external)
Proven experience hosting and participating in regulatory inspections (e.g., MHRA, FDA, EMA)
Demonstrated ability to influence cross-functional teams, provide leadership and drive organisational change.
What we offer:
Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being with access to fitness, mindfulness, and mental health support
Family building benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future